Hillel I Parness ROBINS, KAPLAN, MILLER & CIRESI L.L.P.

601 Lexington Avenue New York, NY 10022 (212) 980-7400

Of Counsel: Ronald J. Schutz Jake M. Holdreith Lars P. Taavola Jamie R. Kurtz ROBINS, KAPLAN, MILLER & CIRESI L.L.P. 2800 LaSalle Plaza 800 LaSalle Avenue Minneapolis, MN 55402 (612) 349-8500

Attorneys for Plaintiff Upsher-Smith Laboratories, Inc.

UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

UPSHER-SMITH LABORATORIES, INC. Plaintiff, v. AUXILIUM PHARMACEUTICALS, INC. AND FCB I LLC, Defendants.

Civil Action No. _________________

COMPLAINT FOR DECLARATORY JUDGMENT (Filed Electronically)

COMPLAINT FOR DECLARATORY JUDGMENT Plaintiff Upsher-Smith Laboratories, Inc., by and through its attorneys, brings this Complaint against Defendants Auxilium Pharmaceuticals, Inc. and FCB I LLC (collectively Defendants) as follows:

83354019.1

THE PARTIES 1. Plaintiff, Upsher-Smith Laboratories, Inc. (USL), is a corporation organized

and existing under the laws of the State of Minnesota, maintaining a principal place of business at 6701 Evenstad Drive, Maple Grove, Minnesota 55369.

2.

Upon information and belief, Defendant Auxilium Pharmaceuticals, Inc.

(Auxilium) is a corporation organized and existing under the laws of the State of Delaware, having its principal place of business at 40 Valley Stream Parkway, Malvern, Pennsylvania 19355. On information and belief, Auxilium contracts with DPT Laboratories Ltd. (DPT) to manufacture its product Testim. Upon information and belief, Auxilium specifically instructed DPT to manufacture Testim at DPTs Lakewood, New Jersey facility.

3.

Upon information and belief, Defendant FCB I LLC (FCB) is a limited liability

company organized and existing under the laws of the State of Delaware, having a principal place of business at 1105 North Market Street, Suite 1300, Wilmington, Delaware 19801. NATURE OF THE ACTION 4. This is a declaratory action seeking a declaration of non-infringement and/or

invalidity of U.S. Patent Nos. 7,608,605 (the 605 patent); 7,608,606 (the 606 patent); 7,608,607 (the 607 patent); 7,608,608 (the 608 patent); 7,608,609 (the 609 patent); 7,608,610 (the 610 patent); 7,935,690 (the 690 patent); and 8,063,029 (the 029 patent). This action arises under the Declaratory Judgment Act, 28 U.S.C. 2201 and 2202, and the Patent Laws of the United States, 35 U.S.C. 100 et seq.

83354019. 12

JURISDICTION AND VENUE 5. This Court has jurisdiction over the subject matter of this action pursuant to 28

U.S.C. 1331, 1338(a), 2201, 2202 and 21 U.S.C. 355(j)(5)(C).

6.

On information and belief, Defendants engage in business in New Jersey and in

this District, and thus, purposefully availed itself of the privilege of doing business in the State of New Jersey and in this District, both generally and specifically, by marketing pharmaceutical products throughout the State of New Jersey, including but not limited to its Testim product that Defendants allege is respectively protected by the patents at issues herein. On information and belief, Defendants have a regular and established place of business in New Jersey and are engaged in carrying on a substantial part of its ordinary business on a permanent basis by contracting with DPT to manufacture its Testim product in DPTs Lakewood, New Jersey facility. This Court also has personal jurisdiction over the Defendants because Defendants have waived any objection to personal jurisdiction by filing suit in this District against Watson Laboratories, Inc. (NV), Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. (collectively Watson) (Civ. Action No. 2:12-cv-03084-JLL-MAH) alleging infringement of the patents at issue herein, by Watson filing Abbreviated New Drug Application (ANDA) No. 09-1073 seeking FDA approval for the commercial manufacture, use and sale of a 1% testosterone gel for topical administration. Venue is proper in this District pursuant to 28 U.S.C. 1391 and/or 1400 because the Defendants are, at a minimum, subject to the personal jurisdiction in this District.

83354019. 13

FACTUAL BACKGROUND 7. Upon information and belief, Defendant Auxilium is a specialty

biopharmaceutical company. Auxilium holds New Drug Application (NDA) No. 21-454 on Testim brand 1% testosterone gel (Testim) and is the exclusive distributor of Testim in the United States.

8.

Upon information and belief, Defendant FCB is a holding company and is the

current assignee of the 605 patent, the 606 patent, the 607 patent, the 608 patent, the 609 patent, the 610 patent, the 690 patent, and the 029 patent (collectively the later-listed patents). Defendant FCB is also the current assignee of U.S. Patent No. 8,178,518 (the 518 patent).

9.

Upon information and belief, the patent applications which led to the later-listed

patents are all continuations of the same patent application U.S. Patent App. Ser. No. 10/473,724. (the 724 application). The 724 application was filed on April 21, 2003 and led to U.S. Patent No. 7,320,968 (the 968 patent).

10.

Upon information and belief, the 605 patent was assigned from CPEX

Pharmaceuticals Inc. (CPEX) to Defendant FCB on April 5, 2011. According to the face of the patent, the 605 patent is titled Pharmaceutical Composition and issued on October 27, 2009. Upon information and belief, Auxilium is a licensee to the 605 patent. A copy of the patent is attached as Exhibit A.

11.

Upon information and belief, the 606 patent was assigned from CPEX to

Defendant FCB on April 5, 2011. According to the face of the patent, the 606 patent is titled
83354019. 14

Pharmaceutical Composition and issued on October 27, 2009. Upon information and belief, Auxilium is a licensee to the 606 patent. A copy of the patent is attached as Exhibit B.

12.

Upon information and belief, the 607 patent was assigned from CPEX to

Defendant FCB on April 5, 2011. According to the face to the patent, the 607 patent is titled Pharmaceutical Composition and issued on October 27, 2009. Upon information and belief, Auxilium is a licensee to the 607 patent. A copy of the patent is attached as Exhibit C.

13.

Upon information and belief, the 608 patent was assigned from CPEX to

Defendant FCB on April 5, 2011. According to the face of the patent, the 608 patent is titled Pharmaceutical Composition and issued on October 27, 2009. Upon information and belief, Auxilium is a licensee to the 608 patent. A copy of the patent is attached as Exhibit D.

14.

Upon information and belief, the 609 patent was assigned from CPEX to

Defendant FCB on April 5, 2011. According to the face of the patent, the 609 patent is titled Pharmaceutical Composition and issued on October 27, 2009. Upon information and belief, Auxilium is a licensee to the 609 patent. A copy of the patent is attached as Exhibit E.

15.

Upon information and belief, the 610 patent was assigned from CPEX to

Defendant FCB on April 5, 2011. According to the face of the patent, the 610 patent is titled Pharmaceutical Composition and issued on October 27, 2009. Upon information and belief, Auxilium is a licensee to the 610 patent. A copy of the patent is attached as Exhibit F.

16.

Upon information and belief, the patent application that led to the 690 patent was

assigned from CPEX to Defendant FCB on April 5, 2011. According to the face of the patent, the 690 patent is titled Pharmaceutical Composition and issued on May 3, 2011. Upon
83354019. 15

information and belief, Auxilium is a licensee to the 690 patent. A copy of the patent is attached as Exhibit G.

17.

Upon information and belief, the patent application that led to the 029 patent was

assigned from CPEX to Defendant FCB on April 5, 2011. According to the face of the patent, the 029 patent is titled Pharmaceutical Composition and issued on November 22, 2011. Upon information and belief, Auxilium is a licensee to the 029 patent. A copy of the patent is attached as Exhibit H.

18.

Upon information and belief, pursuant to 21 U.S.C. 355(b)(1), Auxilium listed

the 968 patent as covering Testim in the Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations prior to October 22, 2008. Upon information and belief, Auxilium listed the later-listed patents, as well as the 518 patent, as covering Testim on or after October 27, 2009.

19.

In 2008, USL submitted an Abbreviated New Drug Application (ANDA) No.

79-178 to the FDA to obtain approval to market a testosterone transdermal gel product in a 1% strength (Testosterone Gel 1%) prior to the expiration of the 968 patent, and prior to the issuance of the later-listed patents. USLs ANDA No. 79-178 contains a certification, pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV)(Paragraph IV Certification).

20.

USL is pursuing FDA approval in order to market its Testosterone Gel 1%

product prior to the expiration of the 968 patent and the later-listed patents.

21.

USL, pursuant to 21 U.S.C. 355(j)(2)(B), provided written notice in 2008 to

Auxilium and Bentley Pharmaceuticals, Inc. (Bentley) that USL had submitted ANDA 79-178.
83354019. 16

USL filed a Paragraph IV certification with the FDA, certifying that the claims of the 968 patent will not be infringed by the commercial manufacture, use or sale of the proposed drug product for which the ANDA was submitted. The written notice that USL provided Auxilium and Bentley stated that USLs commercial manufacture, use and sale of Testosterone Gel 1% would not infringe the 968 patent, and expressly stated that additional legal grounds and factual bases exist regarding the invalidity, unenforceability, and/or non-infringement of certain or all claims of the 968 patent. Upon information and belief, Bentley was CPEX predecessor-in-interest to the 968 patent.

22.

After receiving notice from USL, on December 4, 2008, Auxilium and CPEX

filed suit against USL in the District of Delaware asserting infringement of only the 968 patent. Auxilium Pharmaceuticals, Inc. v. Upsher-Smith Laboratories, Inc., Civil Action No. 08-908SLR (the Delaware action). No other patents are currently asserted in the Delaware action.

23.

On information and belief, after the Delaware action was commenced, Auxilium

listed the later-listed patents in the Orange Book.

24.

On or about April 2012, USL, pursuant to 21 U.S.C. 355(j)(2)(B), provided

written notice to Auxilium and CPEX Pharmaceuticals, Inc. that USL supplemented its Paragraph IV certification for ANDA 79-178 with the FDA, certifying that the claims of the originally listed patent, the 968 patent, and the following later-listed patentsthe 605 patent, the 606 patent, the 607 patent, the 608 patent, the 609 patent, the 610 patent, the 690 patent, and the 029 patentwill not be infringed by the commercial manufacture, use or sale of the proposed drug product for which the ANDA was submitted. The written notice that USL provided Auxilium and CPEX stated that USLs commercial manufacture, use and sale of
83354019. 17

Testosterone Gel 1% would not infringe the 968 patent, and expressly stated that additional legal grounds and factual bases exist regarding the invalidity, unenforceability, and/or noninfringement of certain or all claims of these patents.

25.

In Auxiliums SEC 10-Q filing for the quarterly period ending March 31, 2012,

Auxilium announced that it received a notice from Upsher-Smith in connection with its ANDA advising us and FCB of Upsher-Smiths Paragraph IV certification relating to the eight additional patents listed in the Orange Book in addition to the 968 patent-in-suit, and asserting that Upsher-Smith does not believe that the product for which it is seeking approval infringes any of the Orange Book listed Testim patents and that those patents are invalid.

26.

On information and belief, on May 23, 2012, Auxilium and FCB filed suit in this

District against Watson Laboratories, Inc. (NV), Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. (collectively Watson) (Civ. Action No. 2:12-cv-03084-JLL-MAH) (the Watson action). Upon information and belief, in the Watson action, Auxilium and FCB asserted a claim for infringement of the 968 patent, the later-listed patents, and the 518 patent against Watson.

27.

In a Press Release dated May 17, 2012 announcing the issuance of an additional

patent Mr. Adrian Adams, Chief Executive Officer and President of Auxilium, stated, We are very pleased that, in addition to the nine previously issued patents covering methods using Testim, the franchise is now further protected by a composition patentThis further strengthens our Testim patent estate which we intend to vigorously defend by pursuing all available legal and regulatory options in defense of Testim, including enforcement of all intellectual property rights and approved labeling."

83354019. 18

28.

Auxilium and FCB have demonstrated their intent to prevent generic competition

to its Testim product.

29.

Auxilium has filed suit against USL, asserting the USLs proposed Testosterone

Gel 1% infringes the related 968 patent.

30.

Auxilium and FCB have shown their willingness to assert the later-listed patents

and has already sued Watson in the District of New Jersey, asserting that Watsons proposed testosterone gel infringes the 968 patent and the later-listed patents. The later-listed patents are all continuations of the patent application that led to the 968 patent.

31.

Auxilium and FCB have never disavowed intent to assert that USLs proposed

Testosterone Gel 1% infringes the later-listed patents. To the contrary, Auxilium and FCB have not responded to USLs April 2012 letter and on information and belief, Auxilium has repeatedly told the public that it intends to vigorously defend Testim by pursuing all available legal and regulatory options, including enforcement of all intellectual property rights and approved labeling.

32.

Because Auxilium has previously sued USL for infringement of its proposed

Testosterone Gel 1% product on a related patent, because Auxilium and FCB have filed suit against Watson in this District for its proposed testosterone gel, and because Auxilium and FCB have not responded to USLs April 2012 letter, USL has a reasonable apprehension that Auxilium and FCB will sue USL for infringement of the later-listed patents with respect to USLs proposed Testosterone Gel 1% product.

83354019. 19

33.

To avoid legal uncertainty and to protect its substantial investment in its proposed

Testosterone Gel 1% product, USL has brought these claims for declaratory judgment against the later-listed patents. An actual justiciable controversy exists between the parties as to the infringement and invalidity of the later-listed patents.

34.

Due to the nature of the dispute, USL will seek to consolidate this action with

Watsons action for the purpose of discovery and claim construction.

83354019. 110

COUNT I DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF U.S. PATENT NO. 7,608,605 35. USL hereby restates and realleges the allegations set forth in Paragraphs 1-34

above and incorporates them by reference.

36.

A case or controversy exists between USL and Defendants concerning the non-

infringement of the 605 patent requiring a declaration of rights by this Court.

37.

USLs submission of ANDA 79-178 for the purpose of obtaining approval to

market its Testosterone Gel 1% product did not and does not infringe any valid and enforceable claim of the 605 patent under 35 U.S.C. 271(e)(2), nor would the manufacture, use, sale, offer of sale in and/or importation into the United States of USLs proposed Testosterone Gel 1% infringe any valid and enforceable claim of the 605 patent. USLs making, using, offering to sell, selling, and/or importing Testosterone Gel 1% does not and will not infringe, induce infringement or contribute to infringement by others of any claim of the 605 patent, even under the broadest reasonable construction of the claims of the 605 patent. USL cannot literally (either directly or contributorily) infringe any claim of the 605 patent because one of the components recited in each of the claim of the patent is entirely absent from USLs Testosterone Gel 1%. Moreover, USL cannot infringe (either directly or contributorily) under the doctrine of equivalents. Evidence in the specification and the statements made during prosecution

demonstrate that the patentee recognized that the claimed inventions advancement over the prior art was the inclusion of the specific enhancer oxacyclohexadecan-2-one. The USL formulations are not within scope of the claimed invention, but instead, include only components found in the prior art acknowledged by the patentee during patent prosecution. If any claim of the 605 patent
83354019. 111

were to be interpreted more broadly than this broadest construction, the claim would be invalid. As such, this count is amenable to summary judgment, even prior to a determination on claim construction.

38.

USL is entitled to a declaration that the manufacture, use, sale, offer of sale and/or

importation into the United States of the Testosterone Gel 1% product would not infringe any valid and enforceable claims of the 605 patent. COUNT II DECLARATORY JUDGEMENT OF INVALIDITY OF U.S. PATENT NO. 7,608,605 39. USL hereby restates and realleges the allegations set forth in Paragraphs 1-38

above and incorporates them by reference.

40.

The 605 patent is invalid for failure to meet one or more of the requirements of

patentability under 35 U.S.C. 101, et seq., including, but not limited to, 35 U.S.C. 102 and 103.

41. invalid.

USL is entitled to a declaratory judgment that the claims of the 605 patent are

COUNT III DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF U.S. PATENT NO. 7,608,606 42. USL hereby restates and realleges the allegations set forth in Paragraphs 1-41

above and incorporates them by reference.

83354019. 112

43.

A case or controversy exists between USL and Defendants concerning the non-

infringement of the 606 patent requiring a declaration of rights by this Court.

44.

USLs submission of ANDA 79-178 for the purpose of obtaining approval to

market its Testosterone Gel 1% product did not and does not infringe any valid and enforceable claim of the 606 patent under 35 U.S.C. 271(e)(2), nor would the manufacture, use, sale, offer of sale in and/or importation into the United States of USLs proposed Testosterone Gel 1% infringe any valid and enforceable claim of the 606 patent. USLs making, using, offering to sell, selling, and/or importing Testosterone Gel 1% does not and will not infringe, induce infringement or contribute to infringement by others of any claim of the 606 patent, even under the broadest reasonable construction of the claims of the 606 patent. USL cannot literally (either directly or contributorily) infringe any claim of the 606 patent because one of the components recited in each of the claim of the patent is entirely absent from USLs Testosterone Gel 1%. Moreover, USL cannot infringe (either directly or contributorily) under the doctrine of equivalents. Evidence in the specification and the statements made during prosecution

demonstrate that the patentee recognized that the claimed inventions advancement over the prior art was the inclusion of the specific enhancer oxacyclohexadecan-2-one. The USL formulations are not within scope of the claimed invention, but instead, include only components found in the prior art acknowledged by the patentee during patent prosecution. If any claim of the 606 patent were to be interpreted more broadly than this broadest construction, the claim would be invalid. As such, this count is amenable to summary judgment, even prior to a determination on claim construction.

83354019. 113

45.

USL is entitled to a declaration that the manufacture, use, sale, offer of sale and/or

importation into the United States of the Testosterone Gel 1% product would not infringe any valid and enforceable claims of the 606 patent. COUNT IV DECLARATORY JUDGEMENT OF INVALIDITY OF U.S. PATENT NO. 7,608,606 46. USL hereby restates and realleges the allegations set forth in Paragraphs 1-45

above and incorporates them by reference.

47.

The 606 patent is invalid for failure to meet one or more of the requirements of

patentability under 35 U.S.C. 101, et seq., including, but not limited to, 35 U.S.C. 102 and 103.

48. invalid.

USL is entitled to a declaratory judgment that the claims of the 606 patent are

COUNT V DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF U.S. PATENT NO. 7,608,607 49. USL hereby restates and realleges the allegations set forth in Paragraphs 1-48

above and incorporates them by reference.

50.

A case or controversy exists between USL and Defendants concerning the non-

infringement of the 607 patent requiring a declaration of rights by this Court.

51.

USLs submission of ANDA 79-178 for the purpose of obtaining approval to

market its Testosterone Gel 1% product did not and does not infringe any valid and enforceable

83354019. 114

claim of the 607 patent under 35 U.S.C. 271(e)(2), nor would the manufacture, use, sale, offer of sale in and/or importation into the United States of USLs proposed Testosterone Gel 1% infringe any valid and enforceable claim of the 607 patent. USLs making, using, offering to sell, selling, and/or importing Testosterone Gel 1% does not and will not infringe, induce infringement or contribute to infringement by others of any claim of the 607 patent, even under the broadest reasonable construction of the claims of the 607 patent. USL cannot literally (either directly or contributorily) infringe any claim of the 607 patent because one of the components recited in each of the claim of the patent is entirely absent from USLs Testosterone Gel 1%. Moreover, USL cannot infringe (either directly or contributorily) under the doctrine of equivalents. Evidence in the specification and the statements made during prosecution

demonstrate that the patentee recognized that the claimed inventions advancement over the prior art was the inclusion of the specific enhancer oxacyclohexadecan-2-one. The USL formulations are not within scope of the claimed invention, but instead, include only components found in the prior art acknowledged by the patentee during patent prosecution. If any claim of the 607 patent were to be interpreted more broadly than this broadest construction, the claim would be invalid. As such, this count is amenable to summary judgment, even prior to a determination on claim construction.

52.

USL is entitled to a declaration that the manufacture, use, sale, offer of sale and/or

importation into the United States of the Testosterone Gel 1% product would not infringe any valid and enforceable claims of the 607 patent.

83354019. 115

COUNT VI DECLARATORY JUDGEMENT OF INVALIDITY OF U.S. PATENT NO. 7,608,607 53. USL hereby restates and realleges the allegations set forth in Paragraphs 1-52

above and incorporates them by reference.

54.

The 607 patent is invalid for failure to meet one or more of the requirements of

patentability under 35 U.S.C. 101, et seq., including, but not limited to, 35 U.S.C. 102 and 103.

55. invalid.

USL is entitled to a declaratory judgment that the claims of the 607 patent are

COUNT VII DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF U.S. PATENT NO. 7,608,608 56. USL hereby restates and realleges the allegations set forth in Paragraphs 1-55

above and incorporates them by reference.

57.

A case or controversy exists between USL and Defendants concerning the non-

infringement of the 608 patent requiring a declaration of rights by this Court.

58.

USLs submission of ANDA 79-178 for the purpose of obtaining approval to

market its Testosterone Gel 1% product did not and does not infringe any valid and enforceable claim of the 608 patent under 35 U.S.C. 271(e)(2), nor would the manufacture, use, sale, offer of sale in and/or importation into the United States of USLs proposed Testosterone Gel 1% infringe any valid and enforceable claim of the 608 patent. USLs making, using, offering to

83354019. 116

sell, selling, and/or importing Testosterone Gel 1% does not and will not infringe, induce infringement or contribute to infringement by others of any claim of the 608 patent, even under the broadest reasonable construction of the claims of the 608 patent. USL cannot literally (either directly or contributorily) infringe any claim of the 608 patent because one of the components recited in each of the claim of the patent is entirely absent from USLs Testosterone Gel 1%. Moreover, USL cannot infringe (either directly or contributorily) under the doctrine of equivalents. Evidence in the specification and the statements made during prosecution demonstrate that the patentee recognized that the claimed inventions advancement over the prior art was the inclusion of the specific group of macrocyclic enhancers consisting of 3methylcyclopentadecanone, 9-cycloheptadecen-1-one, cyclohexadecanone, cyclopentadecanone, and oxacyclohexadecan-2-one. The USL formulations are not within scope of the claimed invention, but instead, include only components found in the prior art acknowledged by the patentee during patent prosecution. If any claim of the 608 patent were to be interpreted more broadly than this broadest construction, the claim would be invalid. As such, this claim is amenable to summary judgment, even prior to a determination on claim construction.

59.

USL is entitled to a declaration that the manufacture, use, sale, offer of sale and/or

importation into the United States of the Testosterone Gel 1% product would not infringe any valid and enforceable claims of the 608 patent. COUNT VIII DECLARATORY JUDGEMENT OF INVALIDITY OF U.S. PATENT NO. 7,608,608 60. USL hereby restates and realleges the allegations set forth in Paragraphs 1-59

above and incorporates them by reference.

83354019. 117

61.

The 608 patent is invalid for failure to meet one or more of the requirements of

patentability under 35 U.S.C. 101, et seq., including, but not limited to, 35 U.S.C. 102 and 103.

62. invalid.

USL is entitled to a declaratory judgment that the claims of the 608 patent are

COUNT IX DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF U.S. PATENT NO. 7,608,609 63. USL hereby restates and realleges the allegations set forth in Paragraphs 1-62

above and incorporates them by reference.

64.

A case or controversy exists between USL and Defendants concerning the non-

infringement of the 609 patent requiring a declaration of rights by this Court.

65.

USLs submission of ANDA 79-178 for the purpose of obtaining approval to

market its Testosterone Gel 1% product did not and does not infringe any valid and enforceable claim of the 609 patent under 35 U.S.C. 271(e)(2), nor would the manufacture, use, sale, offer of sale in and/or importation into the United States of USLs proposed Testosterone Gel 1% infringe any valid and enforceable claim of the 609 patent. USLs making, using, offering to sell, selling, and/or importing Testosterone Gel 1% does not and will not infringe, induce infringement or contribute to infringement by others of any claim of the 609 patent, even under the broadest reasonable construction of the claims of the 609 patent. USL cannot literally (either directly or contributorily) infringe any claim of the 609 patent because one of the components recited in each of the claim of the patent is entirely absent from USLs Testosterone

83354019. 118

Gel 1%. Moreover, USL cannot infringe (either directly or contributorily) under the doctrine of equivalents. Evidence in the specification and the statements made during prosecution

demonstrate that the patentee recognized that the claimed inventions advancement over the prior art was the inclusion of the specific enhancer oxacyclohexadecan-2-one. The USL formulations are not within scope of the claimed invention, but instead, include only components found in the prior art acknowledged by the patentee during patent prosecution. If any claim of the 609 patent were to be interpreted more broadly than this broadest construction, the claim would be invalid. As such, this count is amenable to summary judgment, even prior to a determination on claim construction.

66.

USL is entitled to a declaration that the manufacture, use, sale, offer of sale and/or

importation into the United States of the Testosterone Gel 1% product would not infringe any valid and enforceable claims of the 609 patent. COUNT X DECLARATORY JUDGEMENT OF INVALIDITY OF U.S. PATENT NO. 7,608,609 67. USL hereby restates and realleges the allegations set forth in Paragraphs 1-66

above and incorporates them by reference.

68.

The 609 patent is invalid for failure to meet one or more of the requirements of

patentability under 35 U.S.C. 101, et seq., including, but not limited to, 35 U.S.C. 102 and 103.

69. invalid.

USL is entitled to a declaratory judgment that the claims of the 609 patent are

83354019. 119

COUNT XI DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF U.S. PATENT NO. 7,608,610 70. USL hereby restates and realleges the allegations set forth in Paragraphs 1-69

above and incorporates them by reference.

71.

A case or controversy exists between USL and Defendants concerning the non-

infringement of the 610 patent requiring a declaration of rights by this Court.

72.

USLs submission of ANDA 79-178 for the purpose of obtaining approval to

market its Testosterone Gel 1% product did not and does not infringe any valid and enforceable claim of the 610 patent under 35 U.S.C. 271(e)(2), nor would the manufacture, use, sale, offer of sale in and/or importation into the United States of USLs proposed Testosterone Gel 1% infringe any valid and enforceable claim of the 610 patent. USLs making, using, offering to sell, selling, and/or importing Testosterone Gel 1% does not and will not infringe, induce infringement or contribute to infringement by others of any claim of the 610 patent, even under the broadest reasonable construction of the claims of the 610 patent. USL cannot literally (either directly or contributorily) infringe any claim of the 610 patent because one of the components recited in each of the claim of the patent is entirely absent from USLs Testosterone Gel 1%. Moreover, USL cannot infringe (either directly or contributorily) under the doctrine of equivalents. Evidence in the specification and the statements made during prosecution demonstrate that the patentee recognized that the claimed inventions advancement over the prior art was the inclusion of the specific group of macrocyclic enhancers consisting of 3methylcyclopentadecanone, 9-cycloheptadecen-1-one, cyclohexadecanone, cyclopentadecanone, and oxacyclohexadecan-2-one. The USL formulations are not within scope of the claimed
83354019. 120

invention, but instead, include only components found in the prior art acknowledged by the patentee during patent prosecution. If any claim of the 610 patent were to be interpreted more broadly than this broadest construction, the claim would be invalid. As such, this count is amenable to summary judgment, even prior to a determination on claim construction.

73.

USL is entitled to a declaration that the manufacture, use, sale, offer of sale and/or

importation into the United States of the Testosterone Gel 1% product would not infringe any valid and enforceable claims of the 610 patent. COUNT XII DECLARATORY JUDGEMENT OF INVALIDITY OF U.S. PATENT NO. 7,608,610 74. USL hereby restates and realleges the allegations set forth in Paragraphs 1-73

above and incorporates them by reference.

75.

The 610 patent is invalid for failure to meet one or more of the requirements of

patentability under 35 U.S.C. 101, et seq., including, but not limited to, 35 U.S.C. 102 and 103.

76. invalid.

USL is entitled to a declaratory judgment that the claims of the 610 patent are

COUNT XIII DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF U.S. PATENT NO. 7,935,690 77. USL hereby restates and realleges the allegations set forth in Paragraphs 1-76

above and incorporates them by reference.

83354019. 121

78.

A case or controversy exists between USL and Defendants concerning the non-

infringement of the 690 patent requiring a declaration of rights by this Court.

79.

USLs submission of ANDA 79-178 for the purpose of obtaining approval to

market its Testosterone Gel 1% product did not and does not infringe any valid and enforceable claim of the 690 patent under 35 U.S.C. 271(e)(2), nor would the manufacture, use, sale, offer of sale in and/or importation into the United States of USLs proposed Testosterone Gel 1% infringe any valid and enforceable claim of the 690 patent. USLs making, using, offering to sell, selling, and/or importing Testosterone Gel 1% does not and will not infringe, induce infringement or contribute to infringement by others of any claim of the 690 patent, even under the broadest reasonable construction of the claims of the 690 patent. USL cannot literally (either directly or contributorily) infringe any claim of the 690 patent because one of the components recited in each of the claim of the patent is entirely absent from USLs Testosterone Gel 1%. Moreover, USL cannot infringe (either directly or contributorily) under the doctrine of equivalents. Evidence in the specification and the statements made during prosecution demonstrate that the patentee recognized that the claimed inventions advancement over the prior art was the inclusion of the specific group of macrocyclic enhancers consisting of 3methylcyclopentadecanone, 9-cycloheptadecen-1-one, cyclohexadecanone, cyclopentadecanone, and oxacyclohexadecan-2-one. The USL formulations are not within scope of the claimed invention, but instead, include only components found in the prior art acknowledged by the patentee during patent prosecution. If any claim of the 690 patent were to be interpreted more broadly than this broadest construction, the claim would be invalid. As such, this count is amenable to summary judgment, even prior to a determination on claim construction.

83354019. 122

80.

USL is entitled to a declaration that the manufacture, use, sale, offer of sale and/or

importation into the United States of the Testosterone Gel 1% product would not infringe any valid and enforceable claims of the 690 patent. COUNT XVI DECLARATORY JUDGEMENT OF INVALIDITY OF U.S. PATENT NO. 7,935,690 81. USL hereby restates and realleges the allegations set forth in Paragraphs 1-80

above and incorporates them by reference.

82.

The 690 patent is invalid for failure to meet one or more of the requirements of

patentability under 35 U.S.C. 101, et seq., including, but not limited to, 35 U.S.C. 102 and 103.

83. invalid.

USL is entitled to a declaratory judgment that the claims of the 690 patent are

COUNT XV DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF U.S. PATENT NO. 8,063,029 84. USL hereby restates and realleges the allegations set forth in Paragraphs 1-83

above and incorporates them by reference.

85.

A case or controversy exists between USL and Defendants concerning the non-

infringement of the 029 patent requiring a declaration of rights by this Court.

86.

USLs submission of ANDA 79-178 for the purpose of obtaining approval to

market its Testosterone Gel 1% product did not and does not infringe any valid and enforceable

83354019. 123

claim of the 029 patent under 35 U.S.C. 271(e)(2), nor would the manufacture, use, sale, offer of sale in and/or importation into the United States of USLs proposed Testosterone Gel 1% infringe any valid and enforceable claim of the 029 patent. USLs making, using, offering to sell, selling, and/or importing Testosterone Gel 1% does not and will not infringe, induce infringement or contribute to infringement by others of any claim of the 029 patent, even under the broadest reasonable construction of the claims of the 029 patent. USL cannot literally (either directly or contributorily) infringe any claim of the 029 patent because one of the components recited in each of the claim of the patent is entirely absent from USLs Testosterone Gel 1%. Moreover, USL cannot infringe (either directly or contributorily) under the doctrine of equivalents. Evidence in the specification and the statements made during prosecution

demonstrate that the patentee recognized that the claimed inventions advancement over the prior art was the inclusion of the specific group of enhancers consisting of 3-

methylcyclopentadecanone, 9-cycloheptadecen-1-one, cyclohexadecanone, cyclopentadecanone, and oxacyclohexadecan-2-one. The USL formulations are not within scope of the claimed invention, but instead, include only components found in the prior art acknowledged by the patentee during patent prosecution. If any claim of the 029 patent were to be interpreted more broadly than this broadest construction, the claim would be invalid. As such, this count is amenable to summary judgment, even prior to a determination on claim construction.

87.

USL is entitled to a declaration that the manufacture, use, sale, offer of sale and/or

importation into the United States of the Testosterone Gel 1% product would not infringe any valid and enforceable claims of the 029 patent.

83354019. 124

COUNT XVI DECLARATORY JUDGEMENT OF INVALIDITY OF U.S. PATENT NO. 8,063,029 88. USL hereby restates and realleges the allegations set forth in Paragraphs 1-87

above and incorporates them by reference.

89.

The 029 patent is invalid for failure to meet one or more of the requirements of

patentability under 35 U.S.C. 101, et seq., including, but not limited to, 35 U.S.C. 102 and 103.

90. invalid.

USL is entitled to a declaratory judgment that the claims of the 029 patent are

83354019. 125

PRAYER FOR RELIEF WHEREFORE, USL prays this Court: a. Declare that no valid and enforceable claim of the 605 patent, the 606 patent, the

607 patent, the 608 patent, the 609 patent, the 610 patent, the 690 patent, and the 029 patent has been infringed;

b.

Declare that the claims of the 605 patent, the 606 patent, the 607 patent, the

608 patent, the 609 patent, the 610 patent, the 690 patent, and the 029 patent are invalid and/or unenforceable;

c.

Permanently enjoin each Defendant, and its respective agents, servants, officers,

directors, employees, and all persons acting in concert with it, directly or indirectly, from asserting or otherwise seeking to enforce the 605 patent, the 606 patent, the 607 patent, the 608 patent, the 609 patent, the 610 patent, the 690 patent, and the 029 patent against USL or its proposed Testosterone Gel 1% product;

d.

Declare that this case is an exceptional case under 35 U.S.C. 285 and awarding

USL its attorneys fees, costs, and expenses; and

e. equitable.

Award USL any further additional relief as the Court may deem just, proper and

DATED: September 10, 2012

Respectfully submitted,

By: /s/ Hillel Parness Hillel I Parness

83354019. 126

ROBINS, KAPLAN, MILLER & CIRESI L.L.P. 601 Lexington Avenue New York, NY 10022 (212) 980-7400 hiparness@rkmc.com Attorneys for Plaintiff Upsher-Smith Laboratories, Inc.

Of Counsel: Ronald J. Schutz Jake M. Holdreith Lars P. Taavola Jamie R. Kurtz ROBINS, KAPLAN, MILLER & CIRESI L.L.P. 2800 LaSalle Plaza 800 LaSalle Avenue Minneapolis, MN 55402 (612) 349-8500 rjschutz@rkmc.com jmholdreith@rkmc.com lptaavola@rkmc.com jrkurtz@rkmc.com

83354019. 127

CERTIFICATION PURSUANT TO LOCAL CIVIL RULES 11.2 & 40.1 I hereby certify that, to the best of my knowledge, the following action filed in this District involves the validity and/or infringement of the patents recited herein:

Auxilium Pharmaceuticals, Inc. v. Watson Laboratories, Inc. (NV) et al., Civ. Action No. 2:12cv-03084-JLL-MAH (D. N.J. filed May 23, 2012).

I hereby certify, to the best of my knowledge, the following action involves the similar parties and the same ANDA, however, the action involves a different patent than those for which USL is seeking declaration herein:

Auxilium Pharmaceuticals, Inc. v. Upsher-Smith Laboratories, Inc., Civ. Action No. 08-908SLR (D. Del. filed December 4, 2008).

83354019. 128

DATED: September 10, 2012

Respectfully submitted,

By: /s/ Hillel Parness

Hillel I Parness ROBINS, KAPLAN, MILLER & CIRESI L.L.P. 601 Lexington Avenue New York, NY 10022 (212) 980-7400 hiparness@rkmc.com Attorneys for Plaintiff Upsher-Smith Laboratories, Inc.

Of Counsel: Ronald J. Schutz Jake M. Holdreith Lars P. Taavola Jamie R. Kurtz ROBINS, KAPLAN, MILLER & CIRESI L.L.P. 2800 LaSalle Plaza 800 LaSalle Avenue Minneapolis, MN 55402 (612) 349-8500 rjschutz@rkmc.com jmholdreith@rkmc.com lptaavola@rkmc.com jrkurtz@rkmc.com

83354019. 129